Powerful drugs being prescribed off-label to children

By Jessica Nuñez
Association of Health Care Journalists

Robert Farley’s work at the St. Petersburg Times has spanned everything from covering Tampa Bay’s growing Scientology community to contributing to PolitiFact, a Times online project that tracks the presidential candidates. Last summer, however, he hit on a health topic that resonated with the community when he was given six months to investigate the skyrocketing number of atypical antipsychotic drugs being prescribed to children.

The drugs were developed to treat schizophrenia and bipolar disorder in adults, but increasingly have been prescribed off-label to children with aggressive behavior or ADHD. During his investigation, Farley found that almost no research has been done on the long-term effects of these drugs on the developing brains of children. Here, he talks about how he developed two stories about the drugs and a third one that will be published soon.

What first drew your attention to the trend of children being prescribed antipsychotic drugs and what were the first steps you took in investigating it?

To be honest, the idea first came to me while talking to a source, an extremely biased one, about ADHD and different types of drugs used to treat it, including antipsychotics and antidepressants. I was interested and thought there was something there, but I didn’t want to do another ADHD story — that has already been very well reported. I knew that Florida’s Medicaid data was available through state sunshine laws, so I decided to check into it and see what the numbers told me about these drugs.

In Florida, you request the data from the Agency for Health Care Administration, so I originally asked for information about three types of drugs — antipsychotics, antidepressants and drugs for ADHD. The data came back with numbers assigned to patients instead of names, but you get a complete record of drugs prescribed to each child and the doctors prescribing these drugs.

I am not a data person, but I worked closely with a computer-assisted reporting specialist on the Times staff, Connie Humburg. We narrowed our focus down to atypical antipsychotic drugs when we saw that it was clear that that was where the spike in numbers was. The amount of money spent on atypical antipsychotics increased about 400 percent over eight years, and it was obvious there was a story there. I started reading everything I could about atypicals and found 1) that there wasn’t much media coverage and 2) that there was quite a lot of controversy surrounding the appropriate age and for what conditions the drugs should be prescribed.

One thing to note is that, since we had the information about which doctors were prescribing atypical antipsychotics, we thought about publishing a list of the top ten prescribers in the state. We decided against it because the list only includes doctors who prescribe to fee-for-service Medicaid clients and are not a representative sample of other doctors who don’t take these types of patients.

What did you find in your research that was most surprising to you?

I took on this story as an investigative project, but I am not usually on the health beat, so I came into it completely cold. What surprised me the most was the lack of media coverage on atypical antipsychotics and what they were in reality being used for as opposed to what they were originally developed for.

In the article you wrote last July, you used the stories of families going through the dilemma of deciding how to treat their children with behavioral and emotional problems. How did you locate these people and what were some common concerns they expressed?

This was the hardest part of story. The Times has a very strict policy on anonymous sources, which meant I not only had to find people who were going through these experiences, but also people who were willing to have their names in print. Not a lot of parents were thrilled with having their kids’ names in the paper for having these disorders; there is usually a stigma attached.

I got the names of some of the doctors through the Medicaid data (particularly those who were top prescribers of antipsychotics to kids).  I also talked to some doctors just because they were prominent child psychiatrists in the Tampa Bay area, like the head of child psychiatry at All Children's Hospital in St. Petersburg.

As for getting patients, a  few doctors agreed to ask some of  their clients if they would mind talking to a reporter.  If they agreed, then those phone numbers were passed along to me. One doctors did it the other way around and gave a handful of patients my business card.

Even among this group, most didn't want to have their names used. But a few were OK with it. I was very up front with the parents about what we were working on and I was certainly sensitive to not wanting to be exploitative. Some people just wanted to let other parents know what they were going through, to provide support for others in the same situation. And others wanted people to know how difficult these medication decisions are for parents, because sometimes people dismiss them as bad parents who just want to shut up their misbehaving child. 

One woman I had actually met about a year before I did this story, whose son committed suicide. When I first read the story in the papers, I didn’t know that the teenage son was on the atypical Seroquel, a drug that now carries a black box warning for suicidal thoughts in children and teenagers. When I learned about the connection, I contacted her for my story. I attended a support group with the woman and her husband for people whose relatives have committed suicide, and described that particular scene in the article.

How did you find the Medicaid data you used in your story? Is it on the CMS Web site? Did you have to do a lot of analysis or was it pretty straight-forward?

I asked for Florida’s Medicaid data from Agency for Health Care Administration, as I mentioned before. National data is available from CMS, but I wanted to focus on the state level. Every state should have a similar entity to contact for data, and it can even be broken down into county and town as well.

I had about six months to work on this article, and we didn’t know at the beginning how long it would take to get the Medicaid data from the state. We eventually learned that if you ask right away for all the information they have, you will never get it. If you use exactly the right language and put the questions in early, you will get the information a lot faster.

Connie and I went back and forth a lot because sometimes we would get a second set of data we requested that didn’t jog with the first. We would see stuff on the second set that should have been on the first, but was left off. At one point, we had suspicions about the validity of the raw data itself. We also ran into problems because the Medicaid system was changed in 2006, meaning that all the categories and the organization system had changed. The data was the same, but we had to find it in different ways

How did the antipsychotic drugmakers "take over" Medicaid programs across the U.S. and become the top-selling drug category for those public programs?
Atypicals emerged on the market in the late 1990s and were marketed as a wonder drug for treating adults with schizophrenia and bipolar disorder. Little was reported, however, about the high rates of prescription off-label — for kids with ADHD and kids with bipolar. So you had high amounts of atypicals being prescribed off-label without much research. It became popular to use atypicals when doctors couldn’t find anything else that worked, and the numbers just started going up.

How does the lawsuit involving Zyprexa and the push to get it approved for adolescents fit into the larger picture of the antipsychotic prescription trend?

The reason I did the story about Zyprexa was because of an interesting phenomenon we saw in the data. In 2004, the numbers showed that it was the top prescribed drug in Florida, period. That was the same year it peaked, and the numbers sharply fell in 2005. When I looked into it, I found that weight gain and diabetes were being linked to Zyprexa and a number of lawsuits had been filed against the manufacturer, Eli Lilly. Despite all this, not a lot of people had ever even heard the name Zyprexa, many still probably haven’t. I wanted to show an example of how these drugs are marketed, the kinds of problems they cause, and then show how they are still widening their scope, trying to gain approval for adolescents.

For this article, I used SEC filings a lot. From the Web site, you can look in detail at what states have sued a particular company and how much money that company and particular drugs are making.

How do you weave through conflicting medical evidence and decide what is right?

I had some time to work on this project, and that helped a lot because it meant I was able to talk to as many people as I could and cover all bases. That is basically how I decided what to go with — by talking to a lot of people and making sure that I didn’t trust any study at face value. There is a lot of conflicting evidence out there, especially related to the pharmaceutical industry. A great example of this is how these same atypical antipsychotics were touted as wonder drugs when they were first released by people who had a stake in their sale. This permeated the media, although no one looked into what they were actually being prescribed for.

I found and read a ton of studies on PubMed. Usually only the abstracts are available online, but it is a great way to find everything about a certain topic, and then search out the full article elsewhere when you find something directly related to what you’re working on. I found that reading as many studies as possible, many conflicting one another, was a good way to get a clear picture of what was going on.

How do you know if a source/researcher has a conflict of interest and is getting some sort of compensation from a drug firm? How do you check something like this? What tips do you have about spotting these types of people?

I looked at a lot of disclosure statements for academics, which I could look up on the APA [American Psychiatric Association]Web site. I know that Minnesota and Vermont have laws that require doctors to publish any conflicts of interest. I think that should be the law everywhere, but unfortunately it’s not the case in Florida.

How much do you feel obligated to point out the positive aspects of atypical antipsychotic drugs?

I certainly felt we had to be fair and show all sides of the story, and I hope that we were. That’s why we talked to the doctors, and described what the drugs could do when they were really used for what they were meant to be used for — schizophrenia and bipolar in adults.

In a lot of cases, the situation was frustrating for the doctors just as it was for parents. They know that they are operating in gray areas, but they are trying to do the best they can, and they turn to these drugs when they don’t see anything else working.

What will your next article about antipsychotic drugs look closer at?

I recently finished a third installment of the series, the final one before I turn it over to our health writer. I’m still not sure when it will be published, so I don’t want to give away too much, but it is basically about atypicals and the debate over whether or not they are actually better than other drugs for ADHD. It goes a bit deeper into the conflicts of interests and billions of dollars that helped market the drugs.

What are the things that reporters really need to know about this topic and what advice would you offer other reporters who are delving in?

Really, this just isn’t getting enough media attention. We as journalists need to be looking at this with a critical eye and questioning everything that is put out by people that would have a stake in the success of a certain drug. Don’t believe every study that comes across your desk — a lot of times there’s more to the story.

Some other resources I used heavily were ClinicalTrials.gov, a complete registry of federally and privately supported clinical trials, the Lilly Grant Office, where I found the disclosure of grants and contributions funded by Eli Lilly, and the National Institute of Mental Health where I also found statistics and clinical trials. PharmedOut and PsychRights are two advocacy projects for the awareness of inappropriate pharmaceutical promotion practices and against forced psychiatric drugging, respectively.

I really spent a lot of my time looking at blogs related to the pharmaceutical industry just because basically anything that has been written about the topic anywhere in the country is aggregated there. Of course they come with an attitude and a perspective, but they are a great starting point and a good way to stay on top of the news. Some good ones are:

• Pharmalot
• Furious Seasons
• Gooznews.com
• Health Care Renewal